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China Approval of Avastin´s New Indication
As the world's first anti-tumor angiogenesis treatment drug, Avastin was approved in China for the treatment of colorectal cancer and non-small cell lung cancer(NSCLC) indications. On September 21, Roche announced that Avastin has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with recurrent glioblastoma (GBM). Avastin is a humanized monoclonal antibody lgG1 developed by Roche. Avastin can bind to tumor Vascular Endothelial Growth Factor (VEGF) so that it cannot stimulate the growth of blood vessels. The blood, oxygen, and other nutrients required for tumor growth are blocked, preventing their growth or spreading to other parts of the body, and ultimately achieving anti-cancer effects. Glioblastoma (GBM) is the most common and deadly primary brain tumor in adults. In the West, the annual incidence or number of new diagnoses is 2 to 3 per 100,000 people. GBM accounts for 12% to 15% of all intracranial tumors and 50% to 60% of astrocytoma. GBM can invade and infiltrate the normal surrounding brain tissue extensively, making complete resection impossible. Even with comprehensive treatments such as surgery, radiotherapy and chemotherapy, GBM patients are still very prone to relapse and die of tumors quickly. GBM is considered to be one of the most difficult tumors in the field of neurosurgery. The approval of this new indication is mainly based on a multi-center, open-label, randomized controlled, pivotal phase III clinical trial EORTC 26101. The results of this study confirmed that compared with chemotherapy alone, Avastin-based treatment prolonged the time to progression-free survival or the time to death (median PFS: 4.2 months vs. 1.5 months, HR=0.52, 95%CI: 0.41-0.64), the risk of disease progression can be reduced by 51%. During the progression-free survival period, patients in remission showed more stable global health scores and cognitive functions than non-remission patients. This means that Avastin will bring new treatment options for Chinese GBM patients. The approval of Avastin this time fills up the gap in the field of GBM treatment in China. It is of great significance to improving the level of GBM diagnosis and treatment in China, and will bring good news to patients who lack effective treatment options.
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美国最高法院大法官金斯伯格的传奇人
9月19日,据路透社、BBC等多家外媒报道,美国最高法院大法官露丝·巴德·金斯伯格去世,终年87岁。 据悉,金斯伯格在13日晚间出现发烧等症状,并于当晚在华盛顿特区的西布利纪念医院接受初步检查,在14日当天转院至约翰斯·霍普金斯医院。其实在今年7月份,金斯伯格曾宣布癌症复发。金斯伯格大法官的去世轰动了整个美国,不仅成千上万的民众自发到美国最高法院门口表示哀悼,美国白宫也降半旗表示致哀。 美国大法官金斯伯格的传奇一生 1933年金斯伯格出生在纽约布鲁克林,据她本人说,她的父亲是美国第一代移民,她的母亲勉强算上美国第二代移民。金斯伯格的母亲虽然读完高中之后因为家庭原因没能再进学,但是却充满智慧。金斯伯格的母亲交给她两句话:成为淑女,独立生活。不幸的是,在金斯伯格高中毕业时,她的母亲因为身患癌症去世了。 之后,金斯伯格靠着奖学金进入康奈尔大学学习。她在康奈尔大学遇见自己的丈夫马丁,他们在大三时订了婚,毕业之后就结婚了。在大学毕业之后,因为丈夫应召入伍,金斯伯格也跟随丈夫来到俄克拉荷马州,在此期间,她在当地的社会保障部门找了份补助审查员的工作,级别是5级。然而当她告知人事部门她怀孕的消息之后,她就被安排做文员的工作,级别也被降为2级。丈夫退役后,金斯伯格与丈夫马丁进入哈佛大学法学院学习。丈夫马丁毕业之后,在纽约律所找到一份工作,金斯伯格为了和丈夫一起,也转到哥伦比亚大学继续学习。可是即使金斯伯格以第一名的优异成绩毕业,毕业后她仍无法在纽约的律所找到律师的工作,原因是纽约的律所不雇佣女性。 1963年,她去了罗格斯大学任法学教授。后来在学生的要求下,新增了一门“性别与法律的”课程。在授课过程中,金斯伯格了解到美国法律中存在许多性别歧视的条款,她也越来越明白,作为女性,歧视无处不在。1972年,她在美国著名民权组织“美国公民自由联盟”旗下,成立了女性权利项目,开始长达十年的诉讼历程。她参与了超过300起关于性别歧视的案子,有6个案子上诉至美国最高法院,她打赢了5件。 1993年,金斯伯格被克林顿提名并任命为美国联邦最高法院大法官,但她没有停下为女性争取平权的脚步。1996年,一名女生想要报考弗吉尼亚军事学院,但是被告知学院不招收女学员。案子最终上诉至最高法院,在金斯伯格主笔的判决中强调不能仅因性别条件,就否定女性没有接受维吉尼亚学院军事训练的能力和毅力,以性别限制所做的政策,须受到严格的审查,为女性赢得了弗吉尼亚军事学院入学的资格。她通过一件件案子,改变着美国的性别歧视条款,也在人们心中构建女性平权的概念。 金斯伯格大法官对于专利法的独特见解 人们将金斯伯格视为一位坚持正义的平权斗士,殊不知她对于专利法也有着自己的独特见解。 2014年4月美国最高法院审理的Nautilus,Inc.v.Biosig Instruments,Inc.案。案件的争议主要是围绕《美国专利法》第112条第2款规定展开,条款规定:专利说明书在最后部分必须“提出一项或多项专门指出并且清楚声明的权利要求,其对象为申请人所指认的发明”。如何解读该条款提到的清楚且明确的要求成为了案件争议的焦点。最高法院6月份作出判决,金斯伯格大法官代表法院撰写一致意见。金斯伯格大法官在判决中写道:本案双方当事人都同意应当从拥有相关技术领域知识者的角度来判定专利权利要求是否明确;应当根据说明书和专利申请过程来加以解释;应当以专利申请之时作为判定的时间标准。但双方当事人未能达成一致的是112条第2款可以容忍的模糊程度究竟是多大。第112条所规定的明确性要求,必须考虑到语言固有的局限性。另一方面,某种程度的不确定性是“确保为创新提供适当激励的代价”;专利不是写给律师看的,甚至也不是写给一般公众看的,而是写给相关领域的技术人员看的。同时,一项专利必须对其所主张的权利要求范围做出清楚的公示,便于告知他人应该避开的区域。这里采用的标准是要求清楚,但同时承认,绝对明确是不可能达到的。这也与最高法以往的意见一致,法律根据发明的对象,要求专利权的确定性,但不会超过合理的程度。 2017年3月美国最高法院审理的Impression Products,Inc.v. Lexmark International Inc.案。案件争议的焦点主要是专利权穷尽规则是否适用海外销售与平行进口。最高院首席大法官罗伯茨主笔撰写法院意见,金斯伯格大法官撰写部分协同与部分反对意见。主笔的罗伯茨大法官认为专利权人在决定将其产品出售之后,无论是否存在合同上的限制,抑或销售行为发生于国外,该产品上的专利权均发生穷竭。专利权应当服从于有关禁止就商品转让施加限制的普通法原则。专利法的目的就是使专利权人得到经济回报从而促进创新,一旦专利权人出售其产品,专利权人就已经获得了经济回报;何况专利法也没有规定任何依据,可以对该产品的使用和受益作出限制。金斯伯格大法官同意法院关于国内用尽权的判决——专利权人销售对再利用或转售有明确限制的产品的,不得通过侵权诉讼强制执行该限制,因为在美国的销售耗尽了所售产品的美国专利权。但是金斯伯格大法官不同意法院关于国际穷竭的判决,她认为海外销售并不意味着穷竭美国发明家在美国的专利权。她在反对意见中提到专利法是属地法。当发明人获得美国专利时,该专利在国外不提供任何保护。美国专利权人必须向每一个他寻求出售其发明的专有权的国家提出申请。而且专利法因国家而异,每个国家关于发明者、竞争对手和公众在专利发明中的相对权利的法律可能都存在不同。因为海外销售独立于美国专利制度运作,所以说这样的销售耗尽了发明人的美国专利权是没有意义的。
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Another pharmaceutical giant enters the field of CD47
On September 8, 2020, Pfizer made a US$25 million equity investment in Trillium Therapeutics. However, this investment by Pfizer has nothing to do with any partners or pre-emptive rights acquired by Trillium Therapeutics, and these options remain completely open. So, what kind of assets are attracting Pfizer? CD47 is a glycoprotein widely expressed on the surface of a variety of cells. It releases a "don't eat me" signal by connecting with SIRPα on the surface of phagocytes to prevent macrophages from engulfing healthy cells.However, cancer cells cunningly use this mechanism to induce immunosuppression and escape the phagocytosis of macrophages.In recent years, CD47 has gradually become a star target in the field of immuno-oncology, and investment in this field has also shown substantial growth: Trillium Therapeutics is a Canada-based immuno-oncology company dedicated to the development of innovative immunotherapies for the treatment of cancer. The company's clinical projects TTI-621 and TTI-622 are two unique SIRPαFc decoy receptors that can target CD47 and block its activity. TTI-622 is a SIRPa-IgG4-Fc fusion protein, similar to the candidate drug of I-Mab, it has very weak binding to normal red blood cells and does not cause hemagglutination. Current data show that in patients with relapsed/refractory DLBCL who have previously received multiple therapies, TTI-622 has achieved "comparable" results in a joint study with the highest dose of competing products. At the same time, the research results also show that "not all IgG4 are equal", because Xinji terminated its phase I study of its IgG4-CD47 molecule CC-90002 two years ago, and the data of TTI-622 is obviously better than analysts expected. However, using solid single-drug data as a basis makes managers more confident that their drugs will perform better in the combination. TTI-621 is a SIRPa-IgG1-Fc fusion protein, which is characterized by a very low dose to achieve great results. Now, the 1.4 mg/kg dose has been considered to be well tolerated in patients with advanced relapsed/refractory hematological cancers. Trillium Therapeutics plans to continue to evaluate these two projects. Ultimately, the company plans to enter the solid tumor field, and its CEO Jan Skvarka said that Pfizer is very interested in this field. With the revival of interest in CD47 in the pharmaceutical industry, innovative therapies for the CD47-SIRPα pathway are expected to become another fertile new world in the field of tumor immunity.
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